CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 453 enrolled / 453 target
Drug / intervention
Guselkumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04936308
NCT04936308Phase 3ActiveUpdate Overdue (7.9/mo)Completion was 20mo ago

A Phase 3B, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Who Had an Inadequate Response and/or Intolerance to One Prior Anti-Tumor Necrosis Factor Alpha Agent

Janssen Research & Development, LLC·interventional·Posted Jun 23, 2021·Updated Jun 5, 2026

In Brief

A Phase 3 clinical trial evaluating Guselkumab and Placebo for Arthritis, Psoriatic. Active but no longer recruiting, targeting 453 participants across 169 sites in 14 countries.

Signals

Enrollment appears stalled

Detailed Summary

The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) and/or intolerance to a prior anti-tumor necrosis factor (TNF) by assessing the reduction in signs and symptoms of PsA.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Bulgaria, Czechia, Hungary, Israel, Malaysia, Poland, Puerto Rico, Russia, Spain, Turkey (Türkiye), Ukraine, United States
Collaborators--

Timeline

Phase 3Active
20222023202420252026
First PostedJun 23, 2021
Enrollment StartSep 28, 2021
Primary CompletionOct 28, 2024
Study CompletionJul 16, 2026
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 5.0 years ago

Arms & Interventions

Group 1: Guselkumab and Placeboexperimental

Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind.

Drug: GuselkumabDrug: Placebo
Group 2: Guselkumabexperimental

Participants will receive guselkumab SC.

Drug: Guselkumab
Group 3: Placebo Followed by Guselkumabexperimental

Participants will receive placebo SC and will cross over to receive guselkumab SC.

Drug: GuselkumabDrug: Placebo

Interventions

Guselkumabdrug

Participants will receive guselkumab as SC injection.

Placebodrug

Participants will receive matching placebo as SC injection.